A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
NCT ID: NCT03662542
Last Updated: 2023-12-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
214 participants
INTERVENTIONAL
2018-11-20
2021-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Combination Therapy
Participants will receive guselkumab Dose 1 as intravenous (IV) infusion and Dose 2 as subcutaneous (SC) injection; and golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
Guselkumab Dose 1
Guselkumab Dose 1 will be administered as IV infusion.
Guselkumab Dose 2
Guselkumab Dose 2 will be administered as SC injection.
Golimumab Dose 1
Golimumab Dose 1 will be administered as SC injection.
Golimumab Dose 2
Golimumab Dose 2 will be administered as SC injection.
Placebo
Placebo will be administered.
Monotherapy: Guselkumab
Participants will receive guselkumab Dose 1 as IV infusion, Dose 2 as SC injection and placebo to maintain the blind.
Guselkumab Dose 1
Guselkumab Dose 1 will be administered as IV infusion.
Guselkumab Dose 2
Guselkumab Dose 2 will be administered as SC injection.
Placebo
Placebo will be administered.
Monotherapy: Golimumab
Participants will receive golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
Golimumab Dose 1
Golimumab Dose 1 will be administered as SC injection.
Golimumab Dose 2
Golimumab Dose 2 will be administered as SC injection.
Placebo
Placebo will be administered.
Interventions
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Guselkumab Dose 1
Guselkumab Dose 1 will be administered as IV infusion.
Guselkumab Dose 2
Guselkumab Dose 2 will be administered as SC injection.
Golimumab Dose 1
Golimumab Dose 1 will be administered as SC injection.
Golimumab Dose 2
Golimumab Dose 2 will be administered as SC injection.
Placebo
Placebo will be administered.
Eligibility Criteria
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Inclusion Criteria
* Moderately to severely active UC as defined by Mayo score
* History of inadequate response to or failure to tolerate conventional therapy
* Has screening laboratory test results within the study protocol defined parameters
* A woman of childbearing potential must have a negative highly sensitive serum (beta human chorionic gonadotropin) pregnancy test result at screening and a negative urine pregnancy test result at Week 0
Exclusion Criteria
* Has UC limited to the rectum only or to less than (\<) 20 centimeter (cm) of the colon
* Has a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, before screening
* Has any known malignancy or has a history of malignancy (with the exception of basal cell carcinoma; squamous cell carcinoma in situ of the skin; or cervical carcinoma in situ that has been treated with no evidence of recurrence; or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years before screening)
* Has known allergies, hypersensitivity, or intolerance to guselkumab or golimumab or their excipients
18 Years
65 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Precision Research Institute
San Diego, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
GCP Clinical Research
Tampa, Florida, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, United States
Indiana University
Indianapolis, Indiana, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Woodholme Gastroenterology
Glen Burnie, Maryland, United States
Sierra Clinical Research
Las Vegas, Nevada, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Fargo Gastroenterology Clinic, PC
Fargo, North Dakota, United States
Texas Digestive Disease Consultants
Southlake, Texas, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States
Virginia Mason
Seattle, Washington, United States
Washington Gastroenterology, PLLC
Tacoma, Washington, United States
CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
Buenos Aires, , Argentina
Hospital Britanico de Buenos Aires
Buenos Aires, , Argentina
Expertia S.A
Caba, , Argentina
Centro Médico Dra. De Salvo
Caba, , Argentina
Clínica Adventista Belgrano
Ciudad de Buenos Aires, , Argentina
Fundacion de Estudios Clinicos
Rosario, , Argentina
Hospital de Alta Complejidad en Red 'El Cruce'
San Juan Bautista, , Argentina
Sanatorio 9 de Julio
San Miguel de Tucumán, , Argentina
Princess Alexandra Hospital
Brisbane, , Australia
St Vincent's Hospital - Melbourne
Fitzroy, , Australia
Nepean Hospital
Kingswood, , Australia
Royal Adelaide Hospital
North Terrace, , Australia
Macquarie University Hospital
NSW, , Australia
Royal Melbourne Hospital
Parkville, , Australia
Mater Hospital Brisbane (Inflammatory Bowel Diseases)
South Brisbane, , Australia
Hospital Das Clinicas Da Ufmg
Belo Horizonte, , Brazil
Universidade Estadual Paulista 'Julio De Mesquita Filho'
Botucatu, , Brazil
Inst Goiano Gastroenterologia e Endoscopia Digest Ltda - Clinica de Gastro
Goiânia, , Brazil
Hospital das Clinicas de Porto Alegre
Porto Alegre, , Brazil
Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP
Ribeirão Preto, , Brazil
Universidade Federal do Rio de Janeiro - Faculdade de Medicina
Rio de Janeiro, , Brazil
Instituto Brasil de Pesquisa Clinica
Rio de Janeiro, , Brazil
Fundacao do ABC - Centro Universitario FMABC
Santo André, , Brazil
Kaiser Hospta
São José do Rio Preto, , Brazil
Eurolatino Pesquisas Medicas Ltda
Uberlândia, , Brazil
Charite Berlin
Berlin, , Germany
Universitatsklinikum Frankfurt/ Medizinische Klinik 1
Frankfurt, , Germany
Universitätsklinikum Jena
Jena, , Germany
Universitaetsklinikum Ulm
Ulm, , Germany
Clínica Saluz
Boca del Rio, , Mexico
Clinicos Asociados BOCM, SC
Mexico City, , Mexico
Centro Regiomontano de Estudios Clínicos Roma S.C.
Monterrey, , Mexico
Capital Humano para la Investigacion clinica
Querétaro, , Mexico
Centro Medico Zambrano Hellion
San Pedro Garza García, , Mexico
Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdansk, , Poland
Pratia MCM Krakow
Krakow, , Poland
Endoskopia Sp. z o.o. z siedzibą w Sopocie
Sopot, , Poland
Centrum Zdrowia MDM
Warsaw, , Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, , Poland
Centralny Szpital Kliniczny MSWiA w Warszawie
Warsaw, , Poland
Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz
Warsaw, , Poland
Melita Medical Sp. z o.o.
Wroclaw, , Poland
Kazan State Medical University
Kazan', , Russia
City Clinical Hospital # 24
Moscow, , Russia
Medical Center SibNovoMed LLC
Novosibirsk, , Russia
Rostov State Medical University
Rostov-on-Don, , Russia
International Medical Centre SOGAZ
Saint Petersburg, , Russia
Elizavetinskaya hospital
Saint Petersburg, , Russia
Eco-safety Ltd
Saint Petersburg, , Russia
City Clinical Hospital #31
Saint Petersburg, , Russia
Medical University Reaviz
Samara, , Russia
Tver Regional Clinical Hospital
Tver', , Russia
GBUZ Respublican Clinical Hospital n.a. GG Kuvatova
Ufa, , Russia
City Clinical Hospital #2
Yaroslavl, , Russia
Regional Clinical Hospital
Yaroslavl, , Russia
Medical Association 'New Hospital'
Yekaterinburg, , Russia
Communal Nonprofit Enterprise 'City Clinical Hospital # 2 N.A. Prof. O.O. Shalimov'
Kharkiv, , Ukraine
SI 'L.T. Maloyi National Institute of Therapy of National Academy of Medical Sciences of Ukraine
Kharkiv, , Ukraine
Municipal Institution 'Kherson City Clinical Hospital n.a. Y.Y.Karabelesh'
Kherson, , Ukraine
Kyiv City Clinical Hospital #18
Kyiv, , Ukraine
Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'
Kyiv, , Ukraine
Lviv Clinical Hospital on Railway Transport of Affiliate Healthcare center of JSC Ukrainian Railway
Lviv, , Ukraine
Communal Nonprofit Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
Lviv, , Ukraine
Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
Odesa, , Ukraine
Sumy State University, Sumy Regional Clinical Hospital
Sumy, , Ukraine
Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
Ternopil, , Ukraine
Medical Center Ltd 'Health Clinic', Department Of General Therapy
Vinnytsia, , Ukraine
Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov
Vinnytsia, , Ukraine
Countries
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References
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Shao J, Vetter M, Vermeulen A, Feagan BG, Sands BE, Panes J, Xu Z. Combination Therapy With Guselkumab and Golimumab in Patients With Moderately to Severely Active Ulcerative Colitis: Pharmacokinetics, Immunogenicity and Drug-Drug Interactions. Clin Pharmacol Ther. 2024 Jun;115(6):1418-1427. doi: 10.1002/cpt.3235. Epub 2024 Mar 15.
Feagan BG, Sands BE, Sandborn WJ, Germinaro M, Vetter M, Shao J, Sheng S, Johanns J, Panes J; VEGA Study Group. Guselkumab plus golimumab combination therapy versus guselkumab or golimumab monotherapy in patients with ulcerative colitis (VEGA): a randomised, double-blind, controlled, phase 2, proof-of-concept trial. Lancet Gastroenterol Hepatol. 2023 Apr;8(4):307-320. doi: 10.1016/S2468-1253(22)00427-7. Epub 2023 Feb 1.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-001510-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CNTO1959UCO2002
Identifier Type: OTHER
Identifier Source: secondary_id
CR108527
Identifier Type: -
Identifier Source: org_study_id